OncoMatch/Clinical Trials/NCT05645380
Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC
Is NCT05645380 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for triple negative breast cancer.
Treatment: Carboplatin · Docetaxel · Doxorubicin · Cyclophosphamide · Pembrolizumab — This study will assess if the presence of immune system cells in and around the tumor impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for triple-negative breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 ≤ 10% estrogen receptor (ER) staining by IHC (≤ 10% by IHC)
The invasive tumor must be hormone receptor poor, defined as both estrogen receptor (ER) and progesterone receptor staining in ≤ 10% of invasive cancer cells by IHC
Required: PR (PGR) ≤ 10% progesterone receptor (PR) staining by IHC (≤ 10% by IHC)
The invasive tumor must be hormone receptor poor, defined as both estrogen receptor (ER) and progesterone receptor staining in ≤ 10% of invasive cancer cells by IHC
Required: HER2 (ERBB2) HER2-negative (negative)
The invasive tumor must be HER2-negative based on the current ASCO-CAP guidelines
Disease stage
Required: Stage CT1C-T3N0, CT1-T3N1-N2, CTXN1-2 (clinical TNM)
Excluded: Stage IV, STAGE III (IF METASTATIC DISEASE PRESENT)
Histologically confirmed cT1c-T3N0, cT1-T3N1-N2, cTxN1-2 TNBC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
No previous chemotherapy, immunotherapy, endocrine therapy, or radiotherapy for the current breast cancer
Cannot have received: immunotherapy
No previous chemotherapy, immunotherapy, endocrine therapy, or radiotherapy for the current breast cancer
Cannot have received: endocrine therapy
No previous chemotherapy, immunotherapy, endocrine therapy, or radiotherapy for the current breast cancer
Cannot have received: radiation therapy
No previous chemotherapy, immunotherapy, endocrine therapy, or radiotherapy for the current breast cancer
Cannot have received: surgery
No previous ipsilateral breast surgery for the current breast cancer
Cannot have received: anti-PD-1 therapy
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 inhibitor or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA4, OX40, CD137)
Lab requirements
Blood counts
Adequate hematologic function assessed ≤ 21 days from treatment initiation
Kidney function
Adequate renal function assessed ≤ 21 days from treatment initiation
Liver function
Adequate hepatic function assessed ≤ 21 days from treatment initiation
Cardiac function
Only if assigned to Regimen C, LVEF ≥ 50% by echocardiogram or MUGA scan, per standard of care (assessed within 120 days prior to receiving doxorubicin + cyclophosphamide)
Adequate hematologic, hepatic, and renal function assessed ≤ 21 days from treatment initiation. Only if assigned to Regimen C, LVEF ≥ 50% by echocardiogram or MUGA scan, per standard of care (assessed within 120 days prior to receiving doxorubicin + cyclophosphamide)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Kansas Cancer Center - Clinical Research Center · Fairway, Kansas
- The University of Kansas Cancer Center - Main Hospital · Kansas City, Kansas
- The University of Kansas Cancer Center - Westwood · Kansas City, Kansas
- The University of Kansas Cancer Center - Overland Park · Overland Park, Kansas
- The University of Kansas Cancer Center - North · Kansas City, Missouri
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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